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Insulin on Post Burn Hypermetabolism
Plain-language guide to NCT00137254: not phased randomized trial of Insulin (regular human), 14 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00137254
- Phase
- not phased
- Status
- completed
- Start
- 2005-12
- Completion (planned or actual)
- 2007-02
- Participants
- 14 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Burns
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Insulin (regular human).
The purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.
It had 1 arm (groups): A (active comparator).
The registry classes the interventions as drug.
More on the Plan
The results of hypermetabolism persist for weeks to months depending on the severity of the insult.
Massive burns can cause severe catabolism and are an excellent model to study the general effects of injury on protein metabolism.
Who Took Part
The registry lists 14 actual participants took part.
It was open to people of any sex aged from 18 years up to 72 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Between the ages of 18-72 years. Burns occurred within 14 days of coming to burn center.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: heart attack within 3 months; have or have had cancer; seizure disorder.
How the Study Was Run
It was run as a randomized, single-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
Being open-label, the Insulin (regular human) study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2005-12 with completion listed for 2007-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: To assess the relationship of insulin physiologic and molecular effects on skeletal muscle in severely burned patients (time frame: 45 days).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) in 14 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.